Pre-bent tubing 0417150

GUDID E23904171501

No.

Dreve Otoplastik GmbH

Air-conduction hearing aid acoustic tube
Primary Device IDE23904171501
NIH Device Record Key0290aa35-333e-4cf2-aaf7-72592e589bb4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePre-bent tubing
Version Model Number0417150
Catalog Number0417150
Company DUNS315808340
Company NameDreve Otoplastik GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de
Phone+49230388070
Emailotoplastik@dreve.de

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE23904171501 [Primary]

FDA Product Code

ESDHearing Aid, Air-Conduction, Prescription

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-21
Device Publish Date2025-01-13

On-Brand Devices [Pre-bent tubing]

E239045501No.
E239045101No.
E239235501No.
E239235101No.
E239234501No.
E2390411001No.
E239043101No.
E2390431001No.
E239041101No.
E239234101No.
E239042501No.
E23904171501No.
E23904171101No.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.